FDA.reportPublic FDA data

Gabapentin

Product NDC
50090-4893
11-digit product format
500904893
Labeler code
50090
Product ID
50090-4893_764f585e-7e35-4fc5-8b3a-fac25ba5b4ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Gabapentin
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090858
Marketing category
ANDA
Marketing start
2011-01-29
Substance
GABAPENTIN
Active strength
300 mg/1
Pharmacologic classes
Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gabapentin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GABAPENTIN300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6CW7F3G59X
Rxcui310431

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cdc2ae60-922e-452d-a42f-787fe4e2ed06Product name120250123
7059096a-4b9f-36c2-db50-bb5c723e6e9eProduct name220250114
fa3f0129-3502-889f-f424-3a37727959e7Product name920181206
77d89e4c-f57f-326d-d7aa-787f8eebbd2bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4893-02023-02-07C16284748780-1f386c649-b2e7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993
50090-4893-02023-01-30C16284748780-1f386c649-b2e7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use GABAPENTIN CAPSULES safely and effectively. See full prescribing information for GABAPENTIN CAPSULES. GABAPENTIN capsules, for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4893-0Gabapentin90 in 1 BOTTLECAPSULE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4893-0EA - Each50090-4893065b3971-b0c8-41f6-9586-a765d7c26fae12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4893GABAPENTIN CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 1 package rows20230911_77d1d90d-e124-4db7-b811-754d535e579c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310431gabapentin 300 MG Oral CapsulePSN77d1d90d-e124-4db7-b811-754d535e579c5
310431gabapentin 300 MG Oral CapsuleSCD77d1d90d-e124-4db7-b811-754d535e579c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4893-05009048930090 CAPSULE in 1 BOTTLE (50090-4893-0) 90 capsule2020-02-130000-00-00NoNoCurrent